MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ RESPIRATORY VIRAL PANEL; MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT

Catalog Number	445373
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device type: qqx.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of bd max¿ respiratory viral panel, a false negative influenza a patient result was obtained.Sample was repeat tested and remained influenza a negative.Sample was then tested on filmarray, which identified the sample as influenza a positive.Influenza a typing ldt was also performed on residual sample and the result was influenza a positive.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd respiratory viral panel for bd max¿ system assay (ref.(b)(4) lot 5044778 was performed by the review of manufacturing records, retain material testing, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of bd max¿ respiratory viral panel assay indicated that lot 5044778 was manufactured according to specifications and met performance requirements.The retain material of bd respiratory viral panel for bd max¿ system assay (ref.(b)(4) lot 5044778 was tested and the results were as expected.The customer reported discrepancy with flu a detection since the bd respiratory viral panel for bd max¿ system kit lot 5044778 yielded a flu a negative result twice whereas the biofire filmarray identified the sample as flua/h1 positive.According to the customer, after the extraction process using the bd max¿ rvp assay, 5ul of the residual eluate was used to perform an in-house influenza typing test in pcr only, which yielded an h1 positive result with a ct value of 33.Two runs performed using bd respiratory viral panel for bd max¿ system assay were provided for investigation (run #3424 and #3427) and were analyzed.Manual pcr curve adjudication showed no amplification in the cy5 channel (flua target) in either run (a7; run 3424 and b3; run 3427).Further analysis revealed that the internal control (rnasep in the rox channel) showed an amplification curve as expected in both runs, indicating no issue with assay performance.Moreover, although an alternative testing platform identified the sample as flua positive, limits of detection can vary between assays / verification methods, and this may explain the discrepancy observed by the customer.This is further supported by the fact that the customer¿s in-house typing assay yielded a positive result, with a relatively late ct value (33).Such low positive samples can occur due to weak viral titers in the specimen.There is no indication of an increase in complaints for discrepant results for bd respiratory viral panel for bd max¿ system assay from lot 5044778.The root cause was not identified.However, sample at or near the assay lod is the most likely cause to explain the customer¿s discrepant results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard or trends was identified.
Event or Problem Description
It was reported that during use of bd max¿ respiratory viral panel, a false negative influenza a patient result was obtained.Sample was repeat tested and remained influenza a negative.Sample was then tested on filmarray, which identified the sample as influenza a positive.Influenza a typing ldt was also performed on residual sample and the result was influenza a positive.There was no report of patient impact.

• Brand Name: BD MAX¿ RESPIRATORY VIRAL PANEL
• Common Device Name: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24604950
• Report Number: 3007420875-2026-00054
• Device Sequence Number: 9026769
• Product Code: QOF
• UDI-Device Identifier: 00382904453732
• UDI-Public: (01)00382904453732(17)260919(10)5044778
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K230956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/19/2026
• Device Catalogue Number: 445373
• Device Lot Number: 5044778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown